Preoperative Ondansetron Lozenge for Prevention of Postoperative Nausea and Vomiting in Caesarean Section

Postoperative Nausea and Vomiting Clinical Trial

Official title:

Preoperative Ondansetron Lozenge for Prevention of Postoperative Nausea and Vomiting in Caesarean Section: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06254131
• Other study ID #: 36264PR460/12/2023
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2024
• Est. completion date: July 1, 2024

Study information

• Verified date: February 2024
• Source: Tanta University
• Contact: Ahmed M Ibrahim, MD
• Phone: 00201141779238
• Email: ahmed.edib[@]med.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to estimate the effect of preoperative ondansetron lozenge on prevention of postoperative nausea and vomiting in caesarean section.

Description:

Caesarean section has become increasingly popular, and it is the most performed surgical procedure. Despite consciousness allowing the patient to have an early intimate bond with the newborn, the procedure may be associated with complications. Around 30% of individuals undergoing elective procedures under general anesthetic are affected by postoperative nausea and vomiting (PONV). PONV may decrease the quality of recovery and cause aspiration, intracranial hypertension, dehydration, acid-base disturbance, electrolyte imbalance, and neurological deterioration which leads to a prolonged hospital stay and increased medical cost. The latest guidelines for the management of PONV recommend the administration of prophylactic antiemetic drugs (AED) as part of a multimodal therapy in high-risk adults. Ondansetron is generally considered to be the first-line antiemetic for patients because of its favorable side effect profile. Ondansetron reduces the activity of the vagus nerve, which deactivates the vomiting center in the medulla oblongata, and also blocks serotonin receptors in the chemoreceptor trigger zone, Ondansetron is an effective drug in the prevention and treatment of PONV by having low side effects

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Age from 18 to 35 years old.
• American Society of Anesthesiologists (ASA) physical status II.
• Undergoing caesarean section under general anesthesia.

Exclusion Criteria:

• Medical history of alcohol or drug abuse.
• History of allergic reactions or intolerance to any study medications.
• BMI > 40 kg/m2.
• History of nausea and/or vomiting within 24 h prior procedures.
• History of treatment with antiemetic medication for nausea or vomiting within 24 h of their procedure.
• History of chemotherapy treatment within 4 weeks prior to surgery.

Related Conditions & MeSH terms

• Caesarean Section
• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Ondansetron lozenge (Ondalenz ©)
Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery.
• Ondansetron IV
Patients will receive 4 mg of ondansetron IV approximately 30 minutes before the end of surgery.

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	El-Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative nausea and vomiting (PONV)	The incidence of nausea and vomiting will be evaluated through the Bellville scoring scale (lack of nausea and vomiting=0, nausea=1, nausea with belching=2, and vomiting=3).	24 hours postoperatively
Secondary	Severity of postoperative nausea and vomiting (PONV)	Severity of postoperative nausea and vomiting will be scored at 0-4, 4-12, 12-24 hours using Nausea vomiting scores (NVS): [(0, No complaint; 1, Mild degree of nausea; 2, Moderate degree of nausea; 3, Frequent vomiting; 4, Severe vomiting (continuously)].	24 hours postoperatively
Secondary	Degree of patient satisfaction	Degree of patient satisfaction will be assessed on a 5-point Likert scale Patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied ; 5, extremely satisfied).	24 hours postoperatively
Secondary	Adverse effects	Side effects including headache, dry mouth, dizziness, visual disturbances, agitation, and sedation, will be evaluated on admission to the post anesthesia care unit (PACU) until discharge from the hospital.	24 hours postoperatively